US Pharmaceuticals Inc. recalls Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14)…
- Recall date
- December 7, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0427-2019
- FDA classification
- Class II
- Brand / firm
- US Pharmaceuticals Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
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